Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

NCT01433159 | Terminated Phase 2 Results

• 1 other identifier: 011-101-09-043
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief Summary

The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.

Conditions

Pressure Ulcers; Spinal Cord Injury

Keywords

Pressure Ulcers; Spinal Cord Injury; Healthpoint; Xenaderm; 011-101

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score

  Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound \>24 cm x cm, containing necrotic tissue, with heavy exudate)

  baseline, 14 Days

Study Arms (2)

HP011-101

EXPERIMENTAL

Drug: HP011-101 (Xenaderm Ointment)

Various

ACTIVE COMPARATOR

Standard Care at each site other than Xenaderm Ointment or other BCT-containing products

Drug: Standard Care

Interventions

HP011-101 (Xenaderm Ointment) DRUG

The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101.

HP011-101

Standard Care DRUG

No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).

Various

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent, or assent if less than 18 years of age.
• Age 12 years or older, of either sex, and of any race or skin type, provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
• Have pressure ulcers ≤ Stage II severity, ≥ 2 cm² and ≤ 100 cm² in aggregate area (each area will be measured, including ulcer area (cm2), perimeter (cm) and greatest depth (cm) using the ARANZ Silhouette™ wound imaging and measurement device, and will remain at the treating facility for at least three weeks.
• In the opinion of the Investigator, are maintaining an adequate nutritional status and are receiving a full caloric diet, either orally or by tube.
• All female subjects must have a negative urinary pregnancy test at screening.
• Have, within 12 weeks prior to screening, clinical laboratory test results indicating:
• Alkaline phosphatase, ALT, AST, BUN and serum creatinine levels \< 3x upper limit of the Healthpoint normal range
• HbA1C ≤ 12%
• Hemoglobin ≥ 8 g/dL
• The most recently obtained laboratory values must be evaluated against the stated criteria. If these values are not available from a blood sample within 12 weeks of screening, blood must be drawn at screening and these laboratory values determined.
• For ulcers that will require surgical debridement, any debridement modality may be used at baseline, but the ulcer must remain a Stage I or Stage II partial thickness wound after debridement.
• Have spinal cord injuries, which are motor complete or motor incomplete injuries that are based on American Spinal Injury Association (ASIA) Impairment classifications A, B, C, and D.

You may not qualify if:

• Have a spinal cord injury from, epidural abscess, infection, neurodegenerative process, or malignancy.
• Have a known hypersensitivity to any of the test articles or their components.
• Have received therapy with another investigational agent within thirty (30) days of screening.
• Are pregnant or nursing.
• Have received systemic treatment with glucocorticoids for \> 10 consecutive days within 1 week prior to the start of the study.
• Have received chemotherapy or radiation therapy within the past 5 years.
• Have clinical evidence of bacterial or fungal infection of the any open wound per visual/clinical assessment.
• Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy.
• Have had documented osteomyelitis in the ulcer area within 6 months prior to screening.
• Have end-stage renal disease, are receiving treatment for cancer (except for non-melanoma skin cancer within the past five years), or untreated peripheral vascular disease.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (5)

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Carolinas Research

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jaime Dickerson, PhD
• Organization: Smith & Nephew Biotherapeutics

jaime.dickerson@smith-nephew.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 13, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 10, 2014
• Results First Posted: February 10, 2014

Record last verified: 2014-01

Locations

US (5)